Authorisation For The Medicinal Product For Usoumano «Sevelamer Mylan Pharma».

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Sevelamer Mylan Pharma».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-20&atto.codiceRedazionale=15A00301&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved December 30, 2014 # 1636/2014 of Medicine determines: SEVELAMER MYLAN PHARMA Mah: Mylan 20 20124 Milan Italy s.p.a Via Vittor Pisani, Pack "1X180" tablets 800 mg film-coated tablets in HDPE AIC # 043522010 (10) 19J5YU (based on 32) Packaging "800 mg film-coated tablets" 2X180 tablets in HDPE AIC # 043522022 (10) 19J5Z6 (based on 32) Packaging "800 mg film-coated tablets" 3X180 tablets in HDPE
AIC # 043522034 (10) 19J5ZL (based on 32) Packaging "800 mg film-coated tablets" 1X200 tablets in HDPE AIC # 043522046 (10) 19J5ZY (based on 32) Packaging "800 mg film-coated tablets" 2X200 tablets in HDPE AIC # 043522059 (10) 19J60C (based on 32) Packaging "800 mg film-coated tablets" 3X200 tablets in HDPE AIC # 043522061 (10) 19J60F (based on 32) Packaging "800 mg tablets "1X210 film-coated tablets in HDPE AIC # 043522073 (10) 19J60T (based on 32) Packaging" 800 mg film-coated tablets "2X210 tablets in HDPE AIC # 043522085 (10) 19J615 (based on 32) Packaging" 800 mg film-coated tablets "3X210 tablets in HDPE AIC # 043522097 (10) 19J61K (based on 32) pharmaceutical form : film-coated tablet (Tablet).
Composition: each tablet contains 800 mg of sevelamer carbonate.
Active ingredient: 800 mg of sevelamer carbonate.
Other ingredients: Tablet core: lactose colloidal anhydrous zinc stearate coating Film: Macrogol poly (alcolvinilico) copolymer grafted Talc control, packaging (primary and secondary), batch release: vuoi Inviare la Bambola Hispania SL Castle ' 1, Poligono Las Salinas, Spain 08830 Sant Boi de Llobregat batch control: Quinta-Analytica s.r.o.
Pražska ' 10/18 c 1486, Czech Republic Prague 10200 Labor L + S AG 97708 Bad Bocklet-Grossenbrach Germany Mangelsfeld 4, ITEST plus s.r.o.
10, Czech Republic Vapno Vchýnice bile Production, control, 533 16 u Přelouče packaging (primary and secondary): Pharmaceutical Works POLPHARMA S.A.
19, Pelplińskia 83-200 Starogards, Gdański Poland packaging (primary and secondary): Rottendorf Pharma GmbH D-59320 Ennigerloh, Germany 51-61 Ostenfelder Straße Manufacturing packaging farmaca (MPF): Heerenveen 12, Heerenveen Netherlands B.V. 8448 CN Neptunus GE Pharmaceuticals Industrial Zone "Chekanitza-South" 2140 Botevgrad, Bulgaria Production area active ingredient as Sevelamer carbonate Formosa Laboratories, Inc.
36, Hoping Taiwan County, Taoyuan, 338 Louchu Street, medical indications: Sevelamer Mylan Pharma is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer Mylan is also indicated for the Pharma control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Sevelamer Mylan Pharma should be used within the context of a multiple therapeutic approach that could include calcium supplements, 1.25-dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
Classification for the purposes of new listings ' Pack "800 mg film-coated tablets" 1X180 tablets in HDPE AIC # 043522010 (10) 19J5YU (based on 32) ex factory price listings there class (excluding VAT) €76.19 retail price (tax included) €142.92 the classification contained in this determination takes effect, in accordance with art. 11, paragraph 1, last sentence, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, the day following the expiration of the patent or supplementary protection certificate, issued by the Ministry of economic development.
Until the expiry of the period referred to in the preceding paragraph, the medicine SEVELAMER MYLAN PHARMA it is classified, in accordance with art. 12, paragraph 5, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, called class C (nn).
The packs referred to in art. 1, which are not classified listings there band ' for the purposes of this article, are placed, by virtue of art. 12, paragraph 5, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, # 537 as amended, called class C (nn).
Classification for the purpose of the classification for the purposes of providing the medicine SEVELAMER MYLAN PHARMA is the following: medicinal product subject to medical prescription (RR).
Terms and conditions of use of Prescription medicine subject to diagnosis-treatment plan and to the provisions of annex 2 as amended, October 29, 2004-PHT determination direct distribution-Guide, published in the ordinary supplement to the official journal # 259 of November 4, 2004.
Generic drug patent protection the mAh is responsible of full respect for the rights of industrial property relative to the reference product and the patent regulations provisions in force.
The mAh of the generic drug and is also responsible for full compliance with the provisions of art. 14 co. 2 of legislative decree 219/2006 which forces do not include printed matter those parts of the summary of product characteristics of the reference medicinal product referring to indications or dosages still covered by a patent at the time of placing on the market of the medicinal product.
Printed packaging of the medicinal product should be marketed with labels and package leaflets comply with the text annexed to this determination.
It approved the summary of the product characteristics attached to this determination.
Periodic safety update reports PSUR-

At the time of granting the authorisation, the submission of the periodic safety update reports not required for this product. However, the marketing authorisation holder shall submit periodic safety update reports for this product if the product is listed as reference dates (EURD list) referred to in article 107 c, para. 7 of Directive 2010/84/EC and published on the web portal of the European Medicines Agency.
Date of determination: from the day following its publication in the official journal of the Italian Republic.